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The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days
AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous interstitial glucose measurements | Experimental | Variations of interstitial glucose are measured during 14 days with FreeStyle Libre Pro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Pro | Device | Measurements of interstitial glucose variations with FreeStyle Libre Pro |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of hyperglycemia | In percentage, measured before breakfast and diner (fasting blood glucose). Hyperglycemia defined as follows:
| Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatimata SARR SALL, PhD | Contact | 033381219449 | fatimata.sarr@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sophie BOROT, MD, PhD | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | 25000 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003920 | Diabetes Mellitus |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |